Syngenta Seeds, Inc., and Bayer CropScience AG; Availability of Petition for Determination of Nonregulated Status of Soybean Genetically Engineered for Herbicide Tolerance, 13305-13307 [2013-04521]

Download as PDF erowe on DSK2VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices APHIS may begin issuing permits for importation of the fruit or vegetable subject to the identified designated measures if: (1) No comments were received on the PRA; (2) the comments on the PRA revealed that no changes to the PRA were necessary; or (3) changes to the PRA were made in response to public comments, but the changes did not affect the overall conclusions of the analysis and the Administrator’s determination of risk. In accordance with that process, we published a notice 1 in the Federal Register on April 16, 2012 (77 FR 22557–22558, Docket No. APHIS–2012– 0009), in which we announced the availability, for review and comment, of a PRA that evaluates the risks associated with the importation into the continental United States of fresh strawberry (Fragaria spp.) fruit with calyx and short stalk from Egypt. We solicited comments on the notice for 60 days ending on June 15, 2012. We received three comments by that date. They were from a State department of agriculture, an agricultural research center, and a non-profit industry representative. In the PRA, APHIS determined that three plant pests have a high risk potential of being introduced into the United States via the pathway of fresh strawberry fruit from Egypt. Those pests are: Chrysodeixis chalcites, Eutetranychus orientalis, and Spodoptera littoralis. The PRA notes that Eutetranychus orientalis could potentially avoid detection beneath the calyx of the strawberries due to its small size. One commenter cited this potential risk as a phytosanitary concern. The commenter stated that they would be willing to revisit this issue if current mitigation procedures are proven to be effective and without any detections of this mite. We acknowledge the risk that this plant pest could potentially evade detection and be introduced into the United States in the manner referred to by the commenter. However, while the pest itself may potentially evade detection by its small size, its presence can be detected by visible signs of discoloration and damage to fruits and leaves. Additionally, good agricultural practices can effectively suppress or eliminate this pest from fields or prevent infestation. Successful control programs typically include monitoring, cultural, biological, and chemical components, all of which are used as part of Egypt’s standard pre- and post1 To view the notice, the PRA, and the comments we received, go to https://www.regulations.gov/ #!docketDetail;D=APHIS-2012-0009. VerDate Mar<15>2010 15:18 Feb 26, 2013 Jkt 229001 harvest practices for the production of export strawberries. Moreover, APHIS has permitted the entry of commercial strawberries from several countries in Asia, Europe, and South America where this pest of concern occurs. Over several decades, there has only been one interception of Eutetranychus orientalis in strawberry consignments. Another commenter stated that the PRA does not provide for adequate phytosanitary security against any tetranychid mite. In the risk assessment portion of the PRA, the only tetranychid species identified as likely to follow the importation pathway was Eutetranychus orientalis. For the reasons detailed above, we have determined that the application of certain phytosanitary measures coupled with standard industry practices will be adequate to mitigate the risk posed by this pest. Other tetranychid species identified as pests of fresh strawberry were: Tetranychus cinnabarinus (Boisduval), Tetranychus ludeni Zacher, ´ Tetranychus neocalendonicus Andre, and Tetranychus urticae Koch, which are reported as being present in Egypt, but do not meet the definition of quarantine pests, and Tetranychus turkestani, which has been reported as being present in the region, but APHIS did not find sufficient evidence the pest is present in Egypt. The commenter did not discuss any particular species of tetranychid which they believe to be of concern, nor did they present evidence contradicting the information presented in the risk assessment. The third commenter recommended that we adopt specific phytosanitary measures to address the pest risks discussed in the PRA. APHIS has permitted the entry of commercial strawberries from several countries in Asia, Europe, and South America with similar lists of pests of concern (e.g., Jordan and Israel). Based on our knowledge and experience in relation to importation of fresh strawberry fruit from these countries with similar pest lists, we are confident of the efficacy of the designated measures in mitigating the phytosanitary risks posed by the importation of strawberry from Egypt. Finally, the commenter added that we should intensively monitor fresh strawberry from Egypt at the port of entry. An integral part of standard APHIS phytosanitary practices is inspection at the port of entry. For these reasons, together with Egypt’s use of integrated pest management practices in the production of commercial strawberries, APHIS has PO 00000 Frm 00006 Fmt 4703 Sfmt 4703 13305 concluded that commercial strawberries for export from Egypt are unlikely to contain the identified quarantine pests. Accordingly, we have determined that no changes to the PRA are necessary based on these comments. Therefore, in accordance with the regulations in § 319.56–4(c)(2)(ii), we are announcing our decision to begin issuing permits for the importation into the continental United States of fresh strawberry fruit from Egypt subject to the following phytosanitary measures: • The fresh strawberry fruit may be imported into the continental United States in commercial consignments only; • Each consignment of fresh strawberry fruit must be inspected by the national plant protection organization of Egypt and accompanied by a phytosanitary certificate that includes an additional declaration stating that the consignment was inspected and found free of Chrysodeixis chalcites, Eutetrancychus orientalis, and Spodoptera littoralis; and • The fresh strawberry fruit is subject to inspection upon arrival at the U.S. port of entry. These conditions will be listed in the Fruits and Vegetables Import Requirements database (available at https://www.aphis.usda.gov/favir). In addition to these specific measures, fresh strawberry fruit from Egypt will be subject to the general requirements listed in § 319.56–3 that are applicable to the importation of all fruits and vegetables. Authority: 7 U.S.C. 450, 7701–7772, and 7781–7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3. Done in Washington, DC, this 20th day of February 2013. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2013–04475 Filed 2–26–13; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2012–0090] Syngenta Seeds, Inc., and Bayer CropScience AG; Availability of Petition for Determination of Nonregulated Status of Soybean Genetically Engineered for Herbicide Tolerance Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: E:\FR\FM\27FEN1.SGM 27FEN1 13306 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices SUMMARY: We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from Syngenta Seeds, Inc., and Bayer CropScience AG seeking a determination of nonregulated status of soybean designated as event SYHTOH2, which has been genetically engineered for tolerance to the herbicides glufosinate and mesotrione. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Syngenta Seeds, Inc., and Bayer CropScience AG petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. DATES: We will consider all comments that we receive on or before April 29, 2013. You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!documentDetail;D=APHIS-2012-00900001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2012–0090, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road Unit 118, Riverdale, MD 20737–1238. Supporting documents and any comments we receive on this docket may be viewed at https:// www.regulations.gov/ #!docketDetail;D=APHIS-2012-0090 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799–7039 before coming. The petition is also available on the APHIS Web site at https:// www.aphis.usda.gov/brs/aphisdocs/ 12_21501p.pdf. ADDRESSES: Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737– 1236; (301) 851–3954, email: john.t.turner@aphis.usda.gov. To obtain copies of the petition, contact Ms. Cindy Eck at (301) 851–3892, email: cynthia.a.eck@aphis.usda.gov. erowe on DSK2VPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 15:18 Feb 26, 2013 Jkt 229001 Background Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.), the regulations in 7 CFR part 340, ‘‘Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,’’ regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered (GE) organisms and products are considered ‘‘regulated articles.’’ The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition. APHIS has received a petition (APHIS Petition Number 12–215–01p) from Syngenta Seeds, Inc., and Bayer CropScience (BCS) AG of Research Triangle Park, NC, seeking a determination of nonregulated status of soybean designated as event SYHTOH2, which has been genetically engineered to tolerate exposure to the herbicides glufosinate and mesotrione. Glufosinate tolerance is not a new engineered trait in GE soybean, while mesotrione tolerance is a new trait. The petition states that this soybean event is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS’ regulations in 7 CFR part 340. As described in the petition, soybean event SYHTOH2 has been genetically engineered for tolerance to herbicides that inhibit p-hydroxyphenylpyruvate dioxygenase (HPPD), such as mesotrione, and tolerance to applications of glufosinate-ammonium herbicide. Soybean derived from transformation event SYHTOH2 was developed through Agrobacteriummediated transoformation to stably incorporate the genes avhppd-03 and pat into the soybean genome. The gene avhppd-03 encodes the enzyme phydroxyphenylpyruvate dioxygenase (AvHPPD–03) derived from oat (Avena sativa). AvHPPD–03 has lower binding affinity to mesotrione than does native soybean HPPD. When expressed in soybean, avhppd-03 conveys pre-and post-emergence tolerance to mesotrione. PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 The gene pat encodes the enzyme phosphinothricin acetyltransferase (PAT) which, when produced in plants, acetylates L-phosphinothricin, the active form of glufosinate-ammonium herbicide, resulting in post-emergence tolerance. Soybean event SYHTOH2 is currently regulated under 7 CFR part 340. Interstate movement and field tests of soybean event SYHTOH2 have been conducted under notifications acknowledged by APHIS. Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize risk of persistence in the environment after completion of the test. Data are gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These and other data are used by APHIS to determine if the new variety poses a plant pest risk. Paragraph (d) of § 340.6 provides that APHIS will publish a notice in the Federal Register providing 60 days for public comment for petitions for a determination of nonregulated status. On March 6, 2012, we published in the Federal Register (77 FR 13258–13260, Docket No. APHIS–2011–0129) a notice 1 describing our process for soliciting public comment when considering petitions for determinations of nonregulated status for GE organisms. In that notice we indicated that APHIS would accept written comments regarding a petition once APHIS deemed it complete. In accordance with § 340.6(d) of the regulations and our process for soliciting public input when considering petitions for determinations of nonregulated status for GE organisms, we are publishing this notice to inform the public that APHIS will accept written comments regarding the petition for a determination of nonregulated status from interested or affected persons for a period of 60 days from the date of this notice. The petition is available for public review, and copies are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. We are interested in receiving comments regarding potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. We are particularly interested in receiving comments regarding biological, cultural, or ecological issues, 1 To view the notice, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2011-0129. E:\FR\FM\27FEN1.SGM 27FEN1 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices and we encourage the submission of scientific data, studies, or research to support your comments. We also request that, when possible, commenters provide relevant information regarding specific localities or regions as soybean growth, crop management, and crop utilization may vary considerably by geographic region. After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information; any substantive issues identified by APHIS based on our review of the petition and our evaluation and analysis of comments will be considered in the development of our decisionmaking documents. As part of our decisionmaking process regarding a GE organism’s regulatory status, APHIS prepares a plant pest risk assessment to assess its plant pest risk and the appropriate environmental documentation—either an environmental assessment (EA) or an environmental impact statement (EIS)— in accordance with the National Environmental Policy Act (NEPA), to provide the Agency with a review and analysis of any potential environmental impacts associated with the petition request. For petitions for which APHIS prepares an EA, APHIS will follow our published process for soliciting public comment (see footnote 1) and publish a separate notice in the Federal Register announcing the availability of APHIS’ EA and plant pest risk assessment. Should APHIS determine that an EIS is necessary, APHIS will complete the NEPA EIS process in accordance with Council on Environmental Quality regulations (40 CFR part 1500–1508) and APHIS’ NEPA implementing regulations (7 CFR part 372). Authority: 7 U.S.C. 7701–7772 and 7781– 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. Done in Washington, DC, this 22nd day of February 2013. Michael Gregoire, Deputy Administrator, Biotechnology Regulatory Services, Animal and Plant Health Inspection Service. [FR Doc. 2013–04521 Filed 2–26–13; 8:45 am] erowe on DSK2VPTVN1PROD with NOTICES BILLING CODE 3410–34–P VerDate Mar<15>2010 15:18 Feb 26, 2013 Jkt 229001 DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2012–0110] Dow AgroSciences LLC; Availability of Petition for Determination of Nonregulated Status of Soybean Genetically Engineered for Insect Resistance Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from Dow AgroSciences LLC (DAS) seeking a determination of nonregulated status of soybean designated as DAS–81419–2, which has been genetically engineered for resistance to certain lepidopteran pests. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the DAS petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. SUMMARY: We will consider all comments that we receive on or before April 29, 2013. DATES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!documentDetail;D=APHIS-2012-01100001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2012–0110, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road Unit 118, Riverdale, MD 20737–1238. Supporting documents and any comments we receive on this docket may be viewed at https:// www.regulations.gov/ #!docketDetail;D=APHIS-2012-0110 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799–7039 before coming. The petition is also available on the APHIS Web site at https:// ADDRESSES: PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 13307 www.aphis.usda.gov/brs/aphisdocs/ 12_27201p.pdf. Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737– 1236; (301) 851–3954, email: john.t.turner@aphis.usda.gov. To obtain copies of the petition, contact Ms. Cindy Eck at (301) 851–3892, email: cynthia.a.eck@aphis.usda.gov. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Background Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.), the regulations in 7 CFR part 340, ‘‘Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,’’ regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered (GE) organisms and products are considered ‘‘regulated articles.’’ The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition. APHIS has received a petition (APHIS Petition Number 12–272–01p) from Dow AgroSciences LLC of Indianapolis, IN, seeking a determination of nonregulated status of soybean (Glycine max) designated as event DAS–81419–2, which has been genetically engineered for resistance to certain lepidopteran pests. The petition states that this soybean is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS’ regulations in 7 CFR part 340. As described in the petition, soybean event DAS–81419–2 has been genetically engineered to express two insecticidal proteins, Cry1Ac and Cry1F, and phosphinothricin acetyltransferase, or PAT, protein. Soybean event DAS–81419–2 is currently regulated under 7 CFR part 340. Interstate movements and field tests of soybean event DAS–81419–2 E:\FR\FM\27FEN1.SGM 27FEN1

Agencies

[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13305-13307]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04521]


-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0090]


Syngenta Seeds, Inc., and Bayer CropScience AG; Availability of 
Petition for Determination of Nonregulated Status of Soybean 
Genetically Engineered for Herbicide Tolerance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

[[Page 13306]]

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service (APHIS) has received a petition from Syngenta Seeds, 
Inc., and Bayer CropScience AG seeking a determination of nonregulated 
status of soybean designated as event SYHTOH2, which has been 
genetically engineered for tolerance to the herbicides glufosinate and 
mesotrione. The petition has been submitted in accordance with our 
regulations concerning the introduction of certain genetically 
engineered organisms and products. We are making the Syngenta Seeds, 
Inc., and Bayer CropScience AG petition available for review and 
comment to help us identify potential environmental and interrelated 
economic issues and impacts that APHIS may determine should be 
considered in our evaluation of the petition.

DATES: We will consider all comments that we receive on or before April 
29, 2013.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2012-0090-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2012-0090, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2012-
0090 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.
    The petition is also available on the APHIS Web site at https://www.aphis.usda.gov/brs/aphisdocs/12_21501p.pdf.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, 
Environmental Risk Analysis Programs, Biotechnology Regulatory 
Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; 
(301) 851-3954, email: john.t.turner@aphis.usda.gov. To obtain copies 
of the petition, contact Ms. Cindy Eck at (301) 851-3892, email: 
cynthia.a.eck@aphis.usda.gov.

SUPPLEMENTARY INFORMATION: 

Background

    Under the authority of the plant pest provisions of the Plant 
Protection Act (7 U.S.C. 7701 et seq.), the regulations in 7 CFR part 
340, ``Introduction of Organisms and Products Altered or Produced 
Through Genetic Engineering Which Are Plant Pests or Which There Is 
Reason to Believe Are Plant Pests,'' regulate, among other things, the 
introduction (importation, interstate movement, or release into the 
environment) of organisms and products altered or produced through 
genetic engineering that are plant pests or that there is reason to 
believe are plant pests. Such genetically engineered (GE) organisms and 
products are considered ``regulated articles.''
    The regulations in Sec.  340.6(a) provide that any person may 
submit a petition to the Animal and Plant Health Inspection Service 
(APHIS) seeking a determination that an article should not be regulated 
under 7 CFR part 340. Paragraphs (b) and (c) of Sec.  340.6 describe 
the form that a petition for a determination of nonregulated status 
must take and the information that must be included in the petition.
    APHIS has received a petition (APHIS Petition Number 12-215-01p) 
from Syngenta Seeds, Inc., and Bayer CropScience (BCS) AG of Research 
Triangle Park, NC, seeking a determination of nonregulated status of 
soybean designated as event SYHTOH2, which has been genetically 
engineered to tolerate exposure to the herbicides glufosinate and 
mesotrione. Glufosinate tolerance is not a new engineered trait in GE 
soybean, while mesotrione tolerance is a new trait. The petition states 
that this soybean event is unlikely to pose a plant pest risk and, 
therefore, should not be a regulated article under APHIS' regulations 
in 7 CFR part 340.
    As described in the petition, soybean event SYHTOH2 has been 
genetically engineered for tolerance to herbicides that inhibit p-
hydroxyphenylpyruvate dioxygenase (HPPD), such as mesotrione, and 
tolerance to applications of glufosinate-ammonium herbicide. Soybean 
derived from transformation event SYHTOH2 was developed through 
Agrobacterium-mediated transoformation to stably incorporate the genes 
avhppd-03 and pat into the soybean genome. The gene avhppd-03 encodes 
the enzyme p-hydroxyphenylpyruvate dioxygenase (AvHPPD-03) derived from 
oat (Avena sativa). AvHPPD-03 has lower binding affinity to mesotrione 
than does native soybean HPPD. When expressed in soybean, avhppd-03 
conveys pre-and post-emergence tolerance to mesotrione. The gene pat 
encodes the enzyme phosphinothricin acetyltransferase (PAT) which, when 
produced in plants, acetylates L-phosphinothricin, the active form of 
glufosinate-ammonium herbicide, resulting in post-emergence tolerance. 
Soybean event SYHTOH2 is currently regulated under 7 CFR part 340. 
Interstate movement and field tests of soybean event SYHTOH2 have been 
conducted under notifications acknowledged by APHIS.
    Field tests conducted under APHIS oversight allowed for evaluation 
in a natural agricultural setting while imposing measures to minimize 
risk of persistence in the environment after completion of the test. 
Data are gathered on multiple parameters and used by the applicant to 
evaluate agronomic characteristics and product performance. These and 
other data are used by APHIS to determine if the new variety poses a 
plant pest risk.
    Paragraph (d) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register providing 60 days for public comment for 
petitions for a determination of nonregulated status. On March 6, 2012, 
we published in the Federal Register (77 FR 13258-13260, Docket No. 
APHIS-2011-0129) a notice \1\ describing our process for soliciting 
public comment when considering petitions for determinations of 
nonregulated status for GE organisms. In that notice we indicated that 
APHIS would accept written comments regarding a petition once APHIS 
deemed it complete.
---------------------------------------------------------------------------

    \1\ To view the notice, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
---------------------------------------------------------------------------

    In accordance with Sec.  340.6(d) of the regulations and our 
process for soliciting public input when considering petitions for 
determinations of nonregulated status for GE organisms, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the petition for a determination of 
nonregulated status from interested or affected persons for a period of 
60 days from the date of this notice. The petition is available for 
public review, and copies are available as indicated under ADDRESSES 
and FOR FURTHER INFORMATION CONTACT above.
    We are interested in receiving comments regarding potential 
environmental and interrelated economic issues and impacts that APHIS 
may determine should be considered in our evaluation of the petition. 
We are particularly interested in receiving comments regarding 
biological, cultural, or ecological issues,

[[Page 13307]]

and we encourage the submission of scientific data, studies, or 
research to support your comments. We also request that, when possible, 
commenters provide relevant information regarding specific localities 
or regions as soybean growth, crop management, and crop utilization may 
vary considerably by geographic region.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information; any substantive issues identified by APHIS based on our 
review of the petition and our evaluation and analysis of comments will 
be considered in the development of our decisionmaking documents.
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS prepares a plant pest risk assessment to 
assess its plant pest risk and the appropriate environmental 
documentation--either an environmental assessment (EA) or an 
environmental impact statement (EIS)--in accordance with the National 
Environmental Policy Act (NEPA), to provide the Agency with a review 
and analysis of any potential environmental impacts associated with the 
petition request. For petitions for which APHIS prepares an EA, APHIS 
will follow our published process for soliciting public comment (see 
footnote 1) and publish a separate notice in the Federal Register 
announcing the availability of APHIS' EA and plant pest risk 
assessment. Should APHIS determine that an EIS is necessary, APHIS will 
complete the NEPA EIS process in accordance with Council on 
Environmental Quality regulations (40 CFR part 1500-1508) and APHIS' 
NEPA implementing regulations (7 CFR part 372).

    Authority:  7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC, this 22nd day of February 2013.
Michael Gregoire,
Deputy Administrator, Biotechnology Regulatory Services, Animal and 
Plant Health Inspection Service.
[FR Doc. 2013-04521 Filed 2-26-13; 8:45 am]
BILLING CODE 3410-34-P